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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical
510(k) Number K882421
Device Name INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE
Applicant
DERMACARE PRODUCTS, INC.
7651 NATIONAL TURNPIKE
LOUISVILLE,  KT  40214
Applicant Contact KEN POTTS
Correspondent
DERMACARE PRODUCTS, INC.
7651 NATIONAL TURNPIKE
LOUISVILLE,  KT  40214
Correspondent Contact KEN POTTS
Regulation Number878.4400
Classification Product Code
JOS  
Date Received06/13/1988
Decision Date 06/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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